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临床试验/NCT04601064
NCT04601064进行中(未招募)不适用

Peer Supported Collaborative Care to Increase Engagement in Mental Health and Substance Use Disorder Care in HIV Care Settings

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 405 人开始时间: 2022年4月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
405
试验地点
1
主要终点
The Number of Participants with HIV Virologic Suppression

研究概览

简要总结

This is a research study to assess the effectiveness of a peer-led collaborative care model for integrating treatment for substance use and or mental health disorders into HIV care settings.

Depending on whether or not participants enroll in this study, participants will be assigned randomly (by chance, like drawing a number from a hat) to one of two groups. In group 1, participants would receive usual clinical care. In group 2, participants would work with a peer-case manager who would help support participants to engage in substance use or mental health disorder care. Regardless of the group participants are in, participants will fill out a survey when first enrolled in the study, and then again 12 months later.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Individuals 18-99 years old
  • •accessing HIV care at the Bartlett HIV clinic
  • •Screened positive for a Mental health disorder or substance use disorder based on a computerized self-administered screen with Patient Health Questionnaire (PHQ-9)(score>10), General Anxiety Disorder (GAD-7) (score>10), National Institute on Drug Abuse Drug Use Screening Tool: 3 Question Quick Screen (Response of "Yes" to one or more heavy drinking days or "Yes" to use of illegal drugs or prescription drugs for non-medical reasons.
  • •Does not currently have a Mental Health or Substance Use Disorder treatment provider and or not receiving any current treatment (psychotherapy or pharmacotherapy) for Mental Health or Substance Use Disorder.
  • •English speaking

排除标准

  • •Individuals lacking the capacity to consent

研究组 & 干预措施

Collaborate Care (CC) Model

Experimental

For patients randomized to the CC arm, in addition to the provider being alerted to the positive Mental Health and Substance Use Disorder screener, the patient will also be assigned to a peer case manager (P-CM). The P-CM will provide longitudinal care for the patient as part of their care management case load. The collaborative care support team will include the P-CM, a consultant addiction psychiatrist and the patient's HIV provider who will implement a stepped care program consisting of: 1) an initial assessment, determination of and implementation of an individualized care plan to provide; 2) psychosocial and medication adherence support; 3) evidence-based brief intervention incorporating motivational interviewing informed strategies; 4) measurement-based care for Mental Health and Substance Use Disorder provided directly by the HIV primary care provider or in collaboration with specialty Mental Health and Substance Use Disorder services.

干预措施: Collaborative Care Model (Behavioral)

Usual Care (UC)

No Intervention

For patients randomized to the UC referral arm, the patient's HIV provider will receive an electronic alert of the patient's positive screen for a Mental Health and Substance Use Disorder. The patient will not be contacted by the P-CM. The provider, at their discretion, will initiate referral to the psychiatry service available onsite. For patients with Substance Use Disorder, providers refer to the in-clinic Substance Use Disorder treatment program that is managed by a nurse practitioner with Substance Use Disorder care experience. Once referred, the patient is seen by the nurse practitioner (separate from the HIV provider) who manages prescription of and assessment of adherence to buprenorphine, including monitoring of urine toxicology results with support from an addiction counselor. The Bartlett Clinic runs 2 substance use groups weekly and has processes for referral to a higher level of Substance Use Disorder care at offsite Substance Use Disorder treatment programs.

结局指标

主要结局

The Number of Participants with HIV Virologic Suppression

时间窗: Within a 3 month window of the 12 month follow-up (i.e. 3 months before or after the 12 month follow up)

This is defined as a viral load \< 200 copies/ml

次要结局

  • Number of Participants Who Obtain Treatment for Mental Health and Substance Use Disorder(Within 12 month of patient entrance into the study)
  • Number of Participants with Change in Severity of Mental Health and Substance Use Disorder(Changes from baseline to 12 month follow up)
  • Number of Participants with Retention in HIV Care(Within 12 months of patient entrance into the study)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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